title: Patupilone in patients with pretreated metastatic/locally recurrent colorectal cancer: results of the Phase II CINATRA trial.
abstract: BACKGROUND
  Phase I trials of the microtubule stabilising agent patupilone showed encouraging tumour control and response rates in patients with metastatic colorectal cancer.
  
  
  METHODS
  Patients with metastatic or locally recurrent colorectal cancer who had progressed following treatment with oxaliplatin, irinotecan and fluoropyrimidines were treated with patupilone (8 mg/m(2) IV every 3 weeks) in combination with dexamethasone or prednisolone.
  
  
  RESULTS
  The trial was closed early after 29 patients had been enrolled due to concerns about toxicity. 20 patients (71.4 %) experienced at least one grade 3-5 toxicity, most commonly diarrhoea (14 patients), dehydration (7 patients) and lethargy (6 patients). The 12 week progression-free survival rate was 16.7 % (95 % CI 6.1 %-36.5 %) in the 24 patients with a 12 week scan available or who had died prior to the 12 week scan. No complete or partial responses were seen by 12 weeks. The median progression-free survival was 2.6 months (95 % CI 2.3-2.9) and median overall survival was 6.1 months (95 % CI 3.7-8.4).
  
  
  CONCLUSIONS
  Patupilone given at a dose of 8 mg/m(2) IV over 20 min every 3 weeks was associated with high levels of toxicity and no significant evidence of efficacy in patients with pre-treated colorectal cancer.
authors.affiliation: The Royal Marsden, Downs Road, Sutton, SM2 5PT, UK.
authors.forename: S Y
authors.initials: SY
authors.lastname: Moorcraft
authors.forename: I
authors.initials: I
authors.lastname: Chau
authors.forename: C
authors.initials: C
authors.lastname: Peckitt
authors.forename: D
authors.initials: D
authors.lastname: Cunningham
authors.forename: S
authors.initials: S
authors.lastname: Rao
authors.forename: K L
authors.initials: KL
authors.lastname: Yim
authors.forename: A
authors.initials: A
authors.lastname: Walther
authors.forename: C G C A
authors.initials: CG
authors.lastname: Jackson
authors.forename: G
authors.initials: G
authors.lastname: Stamp
authors.forename: J
authors.initials: J
authors.lastname: Webb
authors.forename: G
authors.initials: G
authors.lastname: Smith
authors.forename: A
authors.initials: A
authors.lastname: Gillbanks
authors.forename: C
authors.initials: C
authors.lastname: Swanton
mesh_terms: D000328:Adult; D000368:Aged; D000970:Antineoplastic Agents / Q000009:adverse effects / Q000627:therapeutic use*; D015179:Colorectal Neoplasms / Q000188:drug therapy*; D003967:Diarrhea / Q000139:chemically induced; D034261:Epothilones / Q000009:adverse effects / Q000627:therapeutic use*; D005260:Female; D006801:Humans; D053609:Lethargy / Q000139:chemically induced; D008297:Male; D008875:Middle Aged; D009364:Neoplasm Recurrence, Local / Q000188:drug therapy*; D016896:Treatment Outcome; D050257:Tubulin Modulators / Q000009:adverse effects / Q000627:therapeutic use*
chemical_list: D000970:Antineoplastic Agents; D034261:Epothilones; D050257:Tubulin Modulators; C093788:epothilone B